ClinicalTrials.gov
ClinicalTrials.gov Menu

Angiogenesis Induced in the Elderly by Hyperbaric Oxygen Therapy (ANGIOHBOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02790541
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

Brief Summary:

Recent studies show preliminary evidence of HBOT therapeutic effects on angiogenesis, increased tissue blood flow and oxygenation correlated with tissue function.

Our primary hypothesis is that HBOT will have beneficial effects on the above mentioned organs associated with aging-related malfunctions due to restored mitochondrial function, mobilization of stem cells and induction of angiogenesis.


Condition or disease Intervention/treatment Phase
Aging Device: Hyperbaric Oxygen Therapy Not Applicable

Detailed Description:

The paradigm The accumulation of damage to molecules, cells and tissues over a lifetime that contributes to aging eventually leads to frailty and malfunction. The past decade has seen fundamental advances in our understanding of the aging process and raised optimism that interventions to slow ageing may be on the horizon. The aging process is linked to energy deficit due to tissue hypoxia and mitochondria dysfunction.

  • Mitochondria dysfunction- Mitochondria are the primary generator of energy by means of ATP synthesis and their dysfunction leads to cellular function decline and degenerative changes. In addition, mitochondria dysfunction in stem cells decreases the capabilities for tissue regeneration.
  • Tissue hypoxia- Atherosclerosis is a chronic inflammatory response that damages arterial blood vessels. It begins in childhood and progresses throughout life. A vicious cycle occurs as mitochondrial dysfunction accelerates atherosclerosis and the waning of microvasculature, resulting in decrease blood supply and ensuing relative tissue hypoxia. The decrease oxygen supply to the mitochondria further exacerbates mitochondrial dysfunction.

Hyperbaric oxygen can increase the partial pressure of dissolved (non-hemoglobin-bound) oxygen 20-30 fold and produce two main effects. First, it can eliminate the relative tissue hypoxia induced by atherosclerosis. Second, because mitochondria function is directly influenced by the partial pressure of dissolved oxygen, hyperbaric oxygen can amend mitochondrial dysfunction. Thus, the investigators suggest hyperbaric oxygen as a novel method for breaking the vicious cycle of degeneration and perhaps even for reversing the aging process.

The study is designed as a prospective crossover study aiming to evaluate the therapeutic effects of HBOT on the Brain, Cardiovascular and Immune system, Skin, Erectile (sexual functions), liver and Kidneys, of aging population.

After signing an informed consent form, patients will be invited for baseline evaluations. All patients would be evaluated 3 times - at baseline, after 3 months of follow up, and after additional 3 months of HBOT protocol. The evaluation will include cognitive assessment, questionnaires, MRI scans, blood tests and skin photograph and biopsy. In addition, blood tests will be drawn before and after the 20th, 40th and the 60th sessions for stem cells and mitochondria tests.

Patients will receive 60 daily sessions, 5 days/week, 90 minutes each with 5 minutes air break every 30 minutes, 100% oxygen at 2 ATA.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Blood Flow and Angiogenesis Induced in the Elderly by Hyperbaric Oxygen Therapy
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Treatment
Hyperbaric Oxygen Therapy: 3 months of treatment consisting of 60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week
Device: Hyperbaric Oxygen Therapy
60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 3 months.
Other Name: HBOT

Control/Crossover
Hyperbaric Oxygen Therapy: 3 months control period (no treatment) followed by 3 months of treatment consisting of 60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week
Device: Hyperbaric Oxygen Therapy
60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 3 months.
Other Name: HBOT




Primary Outcome Measures :
  1. Change from baseline of Angiogenesis in brain MRI at 3 and 6 months [ Time Frame: at baseline, 3 and 6 months ]
    imaging will be performed for evaluation of brain changes and angiogenesis processs using MRI perfusion (DSC)

  2. Change from baseline of general cognitive functions index at 3 and 6 months [ Time Frame: at baseline, 3 and 6 months ]
    Patients' cognitive functions will be assessed by Neurotrax computerized cognitive tests to generate the general cognitive index

  3. Change from baseline of exercise VO2 MAX at 3 and 6 months [ Time Frame: at baseline, 3 and 6 months ]
    Using a standard exercise test which includes gas analysis, the change in VO2 maxs will be assessed 3 and 6 months compared to baseline


Secondary Outcome Measures :
  1. Change in number of circulating stem cells (CD34) at 3 and 6 months [ Time Frame: at baseline, 3 and 6 months ]
    Blood samples will be drawn for measurements of CD34 stem cells number analyzed by FACS.

  2. Change from baseline of proteinuria at 3 and 6 months [ Time Frame: at baseline, 3 and 6 months ]
    24-hours urine will be collected from all patients for evaluation of proteinuria

  3. Change from baseline of Methacetin breath test at 3 and 6 months [ Time Frame: at baseline, 3 and 6 months ]
    All patients will undergo Methacetin breath test. Voltile CO2 levels will be compared to evaluate changes in liver function.

  4. Change from baseline in bone density at 3 and 6 months [ Time Frame: at baseline, 3 and 6 months ]
    All patients will undergo Dual-energy X-ray absorptiometry to evaluate the change bone density changes

  5. Change from baseline in quality of life measured by SF-36 form at 3 and 6 months [ Time Frame: at baseline, 3 and 6 months ]
    All patients will fill SF-36 questionnaire to evaluate the change in quality of life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age≥ 65 years
  • Capability to sign informed consent.
  • No cardiac or cerebrovascular ischemia previous events one year prior to inclusion.

Exclusion Criteria:

  • Previous treatment with HBOT for any other reason during the last 3 months prior to inclusion.
  • Any history of malignancy during the last year prior to inclusion.
  • Severe cognitive decline (MMSA<17)
  • Severe chronic renal failure (GFR <30)
  • Uncontrolled diabetes mellitus (HbA1C>8, fasting glucose>200)
  • Immunosuppressant from any reason
  • Contraindications to perform MRI: claustrophobia, allergy to gadolinium, foreign bodies, pacemaker, etc.
  • Active Smoking.
  • Pulmonary diseases such as severe emphysema, moderate-severe obstructive disease.
  • Medical conditions deemed by the investigator to make the patient ineligible for protocol investigations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790541


Locations
Israel
Asaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Amir Hadanny, MD    97289779395    amir.had@gmail.com   
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Responsible Party: Assaf Harofeh MC, MD, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02790541     History of Changes
Other Study ID Numbers: 0172-15-ASF
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Assaf Harofeh MC, Assaf-Harofeh Medical Center:
aging
HBOT
reverse
angiogenesis
elderly
mitochohndria